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Editorial: End of Year Reflections – Is Industry Making Headway

Len Monheit, NPIcenter | Dec 15, 2005

By Len Monheit

We all know that sometimes it’s extremely difficult to get a message communicated. In order to gain attention, you need significance, context and a stage. Even with all three of these, chances are you might not make the exact impact you seek. People will hear you but they don’t register what you’re saying. It might be an issue of attention span, it may be that what you’re saying conflicts with their convictions, and it may simply be an issue of timing.

This past week, we saw yet another example of an article in the media discussing the unregulated supplements industry (Poughkeepsie Journal- December 14). Trade associations and industry spokespersons have for years presented the realities of our regulatory environment and in many cases, challenged each publication making the false assertion – yet these assertions persist. Fundamentally, there is a strong belief ‘out there’ that regulation is lacking, that products are potentially unsafe, and that scientific substantiation is sparse (and some of this applies to both supplements as well as functional food and beverage products). Despite responding on many occasions that it is enforcement will that is lacking, the media and consumer audience see only the net result, not the process.

This is a very difficult perception to change. When media and consumers see essentially no barrier to market entry, their view is reinforced. When products marketed as supplements are targeted by the FDA for touting themselves as potential treatments or preventions to avian flu, as happened this past week, we all suffer. When products presented as supplements draw attention in the US Congress as containing steroid or steroid precursors, either inadvertently or intentionally, (it really doesn’t matter which) the perception of an unregulated, free-wheeling industry is supported, despite our protests that these products are illegal and should be off the market and their purveyors prosecuted. One often wonders, “Are we making progress?”

As we move into the last few weeks of 2005, perhaps it’s a good time to take stock of the current environment and to see exactly where we stand with our issues, compliance and self-regulatory systems, quality control programs, etc. – All the infrastructural elements that need to be built into our platform for future success.

Current issues and headlines certainly suggest that we are facing many of the same challenges as a year ago – media perception included. In addition to the ‘hot’ topics above, we still have an ephedra issue to deal with (at the very least from a media perspective). On the positive/proactive side, industry has certainly become more vocal in asking for enforcement – and gained headlines and positive coverage because of it. Considering quality infrastructure, Certificates of Analysis and analytical method development and validation have received increased attention.

Where do we go from here?

As always, industry’s most interesting dialogue will involve the regulatory/legislative front. As 2005 concludes and 2006 begins with (I dare say) GMPs imminent, an interesting communications opportunity will almost certainly be taken advantage of by the FDA as they issue the final GMP rule. Media pick up will almost certainly, in many cases, cite a litany of examples (many originally presented by Consumerlab.com) where dietary supplement products have not met their label claim. In addition, the limitations of the GMPs are almost certainly to be expressed, specifically safety and claim substantiation. (The fact that substantiation is already dealt with in other regulations will largely be ignored.) Industry’s adversaries will not see the issuing of GMPs as the end of the conflict– nor should we expect them to. Many will also take a ‘wait and see’ approach, leaving the ball squarely in industry’s court in the absence of FDA enforcement will or capabilities.

Dialogue on AERs (Adverse Event Reporting) to set up a mandatory Serious Adverse Event reporting scheme has made progress in recent months. The passing of legislation requiring supplement manufacturers to report serious AERs will ultimately help the overall product safety argument (once data are reviewed) and remove a serious thorn (or threat) to industry. The combination of AERs and GMPs will inevitably make 2006 a year of significant change, and obvious general compliance and support for both AERs and GMPs gives industry a powerful platform for both safety and quality.

Some companies will almost immediately be able to comply with both obligations. Others will immediately take steps to shore up deficiencies, while still others will analyze and implement new systems over time. On the flip side, there will be non-compliant companies. There will also be industry outliers whose products will continue to be obviously contaminated. We know too that there will be hundreds of companies who will immediately begin trumpeting GMP ‘compliance’, ‘certification’, ‘approval’, ‘validation’ and ‘assurance’, in many cases, with no evidence to support their contentions. Consumers, unfortunately, might be no closer to being able to differentiate better companies, and that is a shame.

It is unlikely that the media’s perception of lack of regulation will be immediately disarmed- past history would suggest it might evolve to echo those that criticize DSHEA in general – inadequate regulation. Industry will be able to point to a GMP rule, which adversaries will counter by noting the phase-in period and no enforcement. Industry will point to top-tier compliant organizations and the media will focus on obvious non-compliances. Our researchers will focus on substantiation while detractors will emphasize study deficiencies and limitations.

I would not have the comments above be perceived as unduly negative, rather practical and realistic. Citing (and very liberally paraphrasing) Sun Tzu: “If you understand the likely tactics and behaviors of your adversaries (both within and outside the industry), how can you be defeated (in the long term)?”